Analytical and clinical validation of the 25 OH vitamin D assay for the LIAISON® automated analyzer
Analytical and clinical validation of the 25 OH vitamin D assay for the LIAISON® automated analyzer
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DOI：
10.1016/j.clinbiochem.2004.06.006
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发表时间：
2004-10-01
影响因子：
2.8
通讯作者：
MacFarlane, GD
中科院分区：
文献类型：
--
作者：
Ersfeld, DL;Rao, DS;MacFarlane, GD
目的：提高测定血清25 OH维生素D的方法的准确性、精密度和易用性。我们描述了用于测定25 OH维生素D的自动化、基于抗体和微粒的荧光免疫测定方法的分析和临床验证。设计和方法：LIAISON（R）25 OH维生素D测定是一种快速自动化方法，40分钟内可获得第一个结果，随后的通量为每小时180个样品。根据美国国家临床实验室标准委员会（NCCLS）方案测定精密度和回收率的测定性能特征。根据标准方案测定分析和功能灵敏度。用于方法比较研究的样品来自提交用于25 OH维生素D测定的常规临床样品或来自明显健康的正常志愿者。
Objective: Methods to assess serum 25 OH vitamin D have improved in accuracy, precision, and ease of use. We describe the analytical and clinical validation of an automated, antibody- and microparticle-based, chemiluminescent immunoassay method for the determination of 25 OH vitamin D.Design and methods: The LIAISON(R) 25 OH Vitamin D assay is a rapid automated method with first results available in 40 min, and a Subsequent throughput of 180 samples per hour. Assay performance characteristics of precision and recovery were determined according to the National Committee for Clinical Laboratory Standards (NCCLS) protocols. Analytical and functional sensitivity were determined according to standard protocols. Samples for method comparison studies were obtained from routine clinical samples submitted for 25 OH Vitamin D determination or from apparently healthy normal volunteers.Results: The detection limit for this assay was